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COVID Credit Crunch: 59% of UK Consumers Have Used Credit Cards ‘To Make Ends Meet’ During Pandemic

COVID Credit Crunch: 59% of UK Consumers Have Used Credit Cards ‘To Make Ends Meet’ During Pandemic

70% of consumers prefer Buy Now Pay Later (BNPL) to credit cards due to affordability and ease of management, with 54% saying BNPL will replace their use of credit cards

LONDON–(BUSINESS WIRE)–Marqeta (NASDAQ: MQ), the global modern card issuing platform, has today released a new report highlighting how the economic stress of the pandemic has increased the popularity of credit cards and flexible payment options – such as Buy Now Pay Later (BNPL). The survey of 1,000 UK consumers showed that nearly 3-in-5 (59%) respondents have relied on credit to make ends meet during the pandemic. Yet it also suggests that credit cards could soon be usurped by BNPL as the consumer credit option of choice. Seven out of 10 consumers reported that they prefer BNPL options to credit cards, citing affordability and ease of management as key reasons, while over half (54%) said that BNPL will replace their use of credit cards. This is despite 35% saying they had tried BNPL for the first time during the pandemic.

Worryingly, the survey showed that while having a wider range of credit options has provided essential support during the crisis, some have found themselves falling behind with payments and building up debt:

  • Of those consumers who were already using BNPL solutions before the pandemic, more than two-thirds (67%) reported that their use had increased over the last 12 months. However, more than half (53%) worry that it’s easier to fall into debt with BNPL compared with credit cards.
  • While 70% of consumers are more conscious of their credit card balance post-COVID, and 60% are more aware of budgeting, almost a quarter (23%) of consumers reported having struggled to keep up with minimum monthly card payments during the pandemic.
  • Despite this, 64% of consumers report using credit cards at least once per week and usage is frequent – with over two-fifths (42%) using their credit cards to make five or more purchases a week.

“Credit cards and BNPL have provided a lifeline for many during the pandemic,” says Ian Johnson, SVP, Managing Director, Europe, Marqeta. “The boom in online shopping due to global lockdowns – combined with the ongoing financial insecurity for millions of households – has created a perfect storm for the surge in BNPL and credit card use. Lots of people are living hand to mouth due to the financial strain of COVID and having flexible payment options has helped them to make ends meet – for example, by allowing them to purchase essentials when they need them, while paying for them at a time that suits.”

The shift towards non-traditional payment options has shown that consumers are increasingly looking for new experiences and innovation in payments. The report found that many consumers expressed interest in different types of credit cards, such as a card that supports environmental causes (72%), or a family credit card (43%). Others were keen for more variety in rewards, with lottery rewards and stock portions being popular options. 64% of those surveyed were interested in non-traditional rewards, with 82% interested in building their own rewards programme.

It also found that nearly three quarters (71%) of consumers think that credit history should be built on more than just credit card use – with 68% stating that they would be interested in a product that builds credit history, but is paid off immediately, like a debit card.

“COVID has irreversibly changed the payments industry. Consumers want to be in control of how they pay, with greater transparency, convenience, and the ability to monitor spending driving the shift towards non-traditional payment options,” concludes Johnson. “Offering new, user-friendly payments experiences has long been a battleground for banks. But the ongoing economic fallout of the pandemic means that customers are now looking for innovative payment options that give them true control over their finances. If banks don’t respond to shifting customer demand, they risk being left behind by their more forward-thinking competitors.”

State of Credit Report

To download the Marqeta 2021 State of Credit Report, please visit: https://www.marqeta.com/uk/resources/2021-state-of-credit

About Marqeta

Marqeta is the global modern card issuing platform empowering builders to bring the most innovative products to the world. Marqeta provides developers advanced infrastructure and tools for building highly configurable payment cards. With its open APIs, the Marqeta platform is used by leading European fintechs like Capital on Tap, Lydia and Twisto, who want to easily build tailored payment solutions to create best-in-class experiences and power new modes of money movement. Marqeta is headquartered in Oakland, California, is enabled in 36 countries globally and has offices in London, United Kingdom and Melbourne, Australia. For more information, visit www.marqeta.com, Twitter and LinkedIn.

Robert Fretwell

Spark Communications

[email protected]

KEYWORDS: North America United States Ireland United Kingdom Europe California

INDUSTRY KEYWORDS: Software Technology Professional Services Finance

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Opera GX integrates CORSAIR iCUE to give a splash of color to gamers’ browsing

The world’s first browser designed for gamers ups its game by integrating CORSAIR iCUE to make CORSAIR RGB-enabled setups dynamically respond to browsing. Opening a tab, receiving a message or downloading a file has never looked better.

PR Newswire

OSLO, Norway, Sept. 16, 2021 /PRNewswire/ — Opera GX is introducing iCUE integration that makes CORSAIR gear dynamically respond to browsing. From now on, whenever you start the browser, open a new tab, finish a file download or complete any number of other browsing tasks, your CORSAIR gear will respond with one of a set of custom effects courtesy of Opera GX’s design team – further ensuring that Opera GX is an essential tool for every gamer

 

“Let’s face it: you need to maintain your focus when gaming so you might want to take it easy with your RGB effects. As a browser, Opera GX is the perfect place for you to really let loose and make your setup shine through colors and animations,” said Maciej Kocemba, Head of Opera GX.

Launched in 2019 during E3 in Los Angeles, Opera GX is the world’s first browser designed for gamers and with the things they like in mind.

“We are excited to help enhance the Opera GX browsing experience even further with iCUE support,” said Lauren Premo, Director of Gaming Marketing at CORSAIR. “It’s amazing to see what’s possible with the iCUE ecosystem when paired with creative partners like Opera.“

Let your CORSAIR gear match the colors of your gaming and browsing

Opera GX is all about bringing the immersive gaming experience to browsing. It’s the first browser with a dynamic soundtrack and sound effects. It was also the first browser to include native Discord and Twitch support. Now, with the inclusion of CORSAIR iCUE software, GX is going to illuminate all your CORSAIR gear, from your memory to your mouse, with custom animations whenever you start the browser, open new tabs, finish a file download or activate the RAM, CPU and network limiters.

Gamers can choose from one of multiple preset animation themes or go deeper and individually choose one of the additional effects. They can also import any gif and use it for a specific thing they do in the browser, with just one click.

Opera GX will also display a gif on your CORSAIR keyboard whenever you get a notification from Discord, Twitch, Telegram, Facebook Messenger, Twitter, WhatsApp or Instagram.

iCUE effects are not displayed continuously, but rather when something occurs in the browser. In order to avoid distractions from late night gaming or binge-watching sessions, they can be dimmed in fullscreen mode.

Opera GX gamers can start enjoying iCUE features now with the browsers latest update. Gamers who haven’t yet taken control of their online browsing experience can join the action by downloading it from the Opera GX home page and joining the many million strong community of active users.

Opera GX

Since its inception in 2019, Opera GX has quickly become the browser of choice for millions of gamers seeking a more custom internet experience. Along with countless customization options including color themes, sound effects, background music, and a gaming-inspired design, GX includes CPU, RAM and Network Bandwidth limiters that make the browser less resource-hungry and leave more of the computer’s resources for gaming. The browser also includes a Hot Tabs Killer feature, which lets users “kill” the most resource-draining tabs and GX Cleaner to purge those old unwanted files. Opera GX launched its own Discord server which now has almost 350k members.

About Opera
Opera is a global web innovator. Opera’s browsers, news products and fintech solutions are the trusted choice of hundreds of millions people worldwide. Opera is headquartered in Oslo, Norway and listed on the NASDAQ stock exchange (OPRA).

About CORSAIR
CORSAIR (NASDAQ: CRSR) is a leading global developer and manufacturer of high-performance gear and technology for gamers, content creators, and PC enthusiasts. From award-winning PC components and peripherals, to premium streaming equipment and smart ambient lighting, CORSAIR delivers a full ecosystem of products that work together to enable everyone, from casual gamers to committed professionals, to perform at their very best.

CORSAIR also includes subsidiary brands Elgato, which provides premium studio equipment and accessories for content creators, SCUF Gaming, which builds custom-designed controllers for competitive gamers, and ORIGIN PC, a builder of custom gaming and workstation desktop PCs and laptops.

Copyright © 2021 Corsair Memory, Inc. All rights reserved. CORSAIR, the sails logo, and Vengeance are registered trademarks of CORSAIR in the United States and/or other countries. All other company and/or product names may be trade names, trademarks, and/or registered trademarks of the respective owners with which they are associated. Features, pricing, availability, and specifications are subject to change without notice.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/opera-gx-integrates-corsair-icue-to-give-a-splash-of-color-to-gamers-browsing-301378376.html

SOURCE Opera Limited

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Silverback Therapeutics Presents Interim Clinical Results from the Ongoing Phase 1/1b Study of SBT6050 Alone or In Combination with Pembrolizumab in Patients with Advanced or Metastatic HER2-Expressing Solid Tumors

Silverback Therapeutics Presents Interim Clinical Results from the Ongoing Phase 1/1b Study of SBT6050 Alone or In Combination with Pembrolizumab in Patients with Advanced or Metastatic HER2-Expressing Solid Tumors

– Proof-of-mechanism established with activation of myeloid and T/NK cells, and evidence of SBT6050 payload localization in the tumor microenvironment –

– SBT6050 demonstrated a manageable safety profile with adverse events consistent with on-mechanism immune activation, both as a monotherapy or in combination with pembrolizumab –

– Early signals of anti-tumor activity observed in a heavily pre-treated, heterogeneous population –

– Management to host conference call today at 6:30 AM ET –

SEATTLE–(BUSINESS WIRE)–
Silverback Therapeutics, Inc. (Nasdaq: SBTX) (“Silverback”), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today presented interim clinical results from a Phase 1/1b clinical study of SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors, at the 2021 European Society for Medical Oncology Congress.

“Over this past year, we have gathered compelling data with clear signals of SBT6050’s pharmacological activity, marked by the activation of both the innate and adaptive immune response in patients,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “We look forward to moving into expansion cohorts and to expanding our clinical development plan to include combination with standard-of-care trastuzumab-containing regimens.”

As of August 1, 2021, 40 patients with advanced or metastatic HER2-expressing or amplified solid tumors were enrolled into the SBT6050-101 trial. SBT6050 dose levels ranged from 0.3 to 1.2 mg/kg in the monotherapy dose escalation arm (Part 1), and 0.15 and 0.3 mg/kg in the pembrolizumab combination arm (Part 3). Patients received between 1 and 17 doses of SBT6050.

As a monotherapy and in combination with pembrolizumab, SBT6050 was generally well-tolerated, with an adverse event profile that is consistent with immune system activation and considered on-mechanism. “The adverse event profile thus far has been very manageable and importantly, suggests the potential to combine with other standard of care agents,” said Samuel Klempner, MD, Medical Oncologist at the Massachusetts General Hospital. “The signals of anti-tumor activity are encouraging and its complementary mechanism of action with standard-of-care agents makes SBT6050 attractive for combination regimens.”

Initial Safety Data

  • The most frequent treatment-related adverse events were consistent with immune activation, and included injection site reactions, fever and chills, hypotension, nausea, vomiting, and fatigue. These were mostly Grade 1 or 2 in nature, and no Grade 4 or higher related adverse events were reported.
  • At higher dose levels, dose limiting toxicities (DLTs) were observed and included Grade 3 hypotension, injection site reaction, fever, and hypoxia. These DLTs resolved with supportive care.
  • Cytokine release syndrome (CRS) > Grade 2 was not observed at any dose level.

Pharmacokinetic and Pharmacodynamic Data

  • SBT6050 exposures increased with dose and exhibited a linear PK profile at 0.6 mg/kg and higher. Linear exposure is evidence of saturation of receptor mediated clearance.
  • Conjugate stability was assessed using a highly sensitive assay, and no active levels of SBT6050’s free payload were detected in the blood and any amount of free payload was absent in 98% of all blood samples tested.
  • SBT6050 induces pharmacologic activity indicative of myeloid and NK/T cell activation at all dose levels, with effects plateauing at 0.6 mg/kg.
  • Pharmacodynamic activity is maintained with repeat dosing of SBT6050.

Anti-Tumor Activity

  • Early signals of anti-tumor activity were observed in a heavily pre-treated, heterogeneous population.
  • Among 18 evaluable patients for tumor types of interest, one patient with HER2 IHC 2+ NSCLC had a confirmed partial response (-55% per RECIST 1.1 criteria), maintained at the most recently available scan obtained at 36 weeks post-enrollment, and 8 weeks after discontinuing study treatment. In addition, stable disease was reported in seven patients.

SBT6050 targets the pertuzumab binding domain of HER2 and is designed to be used in combination with standard of care agents, including trastuzumab-containing regimens. Silverback will be discussing details of its expanded clinical development strategy on the scheduled investor webcast today.

Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

Silverback’s management team will host a conference call today at 6:30 AM ET. A live webcast, including slides, can be accessed through the Events section of the Company’s website at https://ir.silverbacktx.com/news-events/events. An archived replay will be available shortly after the conclusion of the event.

About SBT6050

SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-containing therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.

About Silverback Therapeutics

Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Silverback’s plans and ability to bring new treatments to patients in need, including potential combination efforts, and the progress and expected timing of Silverback’s drug development programs and clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Silverback may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Silverback faces, please refer to Silverback’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Silverback assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Miguel Arcinas

Silverback Therapeutics

(206) 736-7946

[email protected]

Media Contact:

Jason Spark

Canale Communications

(619) 849-6005

[email protected]

KEYWORDS: United States North America Washington

INDUSTRY KEYWORDS: Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology

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Square announces Early Access Program to its Product Ecosystem for Spanish Businesses

Square announces Early Access Program to its Product Ecosystem for Spanish Businesses

The program, with limited space, is available to all types of companies that want to test Square’s services prior to general availability

Square services include point-of-sale software and hardware to accept in-store and online payments, as well as tools to build an online store

Spain is the third European country where Square has launched this year, after its recent entries in Ireland and France

MADRID–(BUSINESS WIRE)–Square, the globally recognized software, payments, and hardware solution for all types of businesses, today announces the launch of its Early Access Program in Spain. The service, which is now available for beta-testing in Spain, offers exclusive access to an integrated set of omnichannel tools for businesses and freelancers to sell and deliver their services more easily, both in-store and online. This program, which is available for a limited time, is now looking for SMEs and larger businesses throughout Spain that want exclusive access to comprehensive solutions that are used by millions of businesses around the world. Merchants who enroll in the Early Access Programme can get started with Square products in just days, with no long-term contracts or start-up fees, and qualify for free Square hardware.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210916005162/en/

Square announces Early Access Program to its Product Ecosystem for Spanish Businesses (Photo: Business Wire)

Square announces Early Access Program to its Product Ecosystem for Spanish Businesses (Photo: Business Wire)

With an ecosystem of products that fully integrate with each other, Square offers all-in-one solutions for multiple business needs: creating online stores, accepting physical card payments, accessing revenue faster, managing inventory or a busy kitchen, and easily setting up appointments, among many other services tailored to save businesses time and make it easier for them to adapt and grow. The company seeks to provide all the tools necessary for businesses and entrepreneursto start, manage, grow, or adapt their business, as needs evolve.

“Setting up my Square products was really easy and we were able to take payments from day one,” said Carlos Tallon, who owns Pasteleria Tallon. “The transaction speed has been impressive, helping us serve even more customers during busy periods. The Square design is a perfect accompaniment to the look and feel of our Pasteleria and integrates seamlessly with our Square software, allowing us to accept payments online and offline.”

Square continues its European expansion with a focus on Spain, a country where 99% of companies are SMEs

Already used by millions of businesses around the world, this is the first time Square is available to Spanish companies and freelancers. The company, founded in 2009 and headquartered in San Francisco, was already present in Australia, Canada, Japan, the United Kingdom, and the United States. This year it began further expansion in Europe, with the launch of its services in Ireland and, more recently, in France. Spain is now the third European country where Square has landed this year, a market in which SMEs account for 99% of the company’s business.

“We’re delighted to bring Square’s integrated suite of products and services to Spanish businesses,” says Jason Lalor, Square’s Executive Director for Europe. “Our omnichannel ecosystem of hardware and software has been designed with businesses of all types and sizes in mind, to help them adapt, run and grow. We’re excited to begin partnering with Spain’s rich business community to refine and enhance our products before the official launch, ensuring we deliver the solutions Spanish businesses need to thrive, both in person and online.”

An Early Access Program with limited capacity

Spanish retailers interested in accessing Square’s Early Access Program should visit https://squareup.com/es/es/espana-aa for more information and to secure their place. These places are limited and are granted on a first-come, first-served basis. Square plans to launch its products for general availability in Spain in 2022.

About Square

Square, Inc. (NYSE: SQ) builds tools to empower businesses and individuals to participate in the economy. Sellers use Square to reach buyers online and in person, manage their business, and access financing. Individuals use Cash App to spend, send, store, and invest money. And TIDAL is a global music and entertainment platform that expands Square’s purpose of economic empowerment to artists. Square, Inc. has offices in the United States, Canada, Japan, Australia, Ireland, France, Spain, Norway, and the UK.

For more information, please visit: https://squareup.com/us/es/about

Ana Mohamed | Angy Morales

[email protected]

+34 699 47 17 38

KEYWORDS: Ireland United States United Kingdom North America Spain Europe California

INDUSTRY KEYWORDS: Professional Services Retail Other Retail Technology Software Banking Hardware

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Square announces Early Access Program to its Product Ecosystem for Spanish Businesses (Photo: Business Wire)
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Almost Half of UK Consumers have Missed Public Sector Appointments due to Communication Issues Since Start of Pandemic, According to Research from Vonage

Almost Half of UK Consumers have Missed Public Sector Appointments due to Communication Issues Since Start of Pandemic, According to Research from Vonage

  • Figure soars to 70 percent of 18-24 year-olds, suggesting that the UK public sector may be failing to provide customer experience that is fit for purpose
  • Research from Vonage underscores the need for organisations to integrate voice chat, SMS and social messaging apps for a unified and streamlined agent and customer experience to serve customers on their preferred channel

LONDON–(BUSINESS WIRE)–Vonage (Nasdaq: VG), a global leader in cloud communications helping businesses accelerate their digital transformation, today announced new research revealing that 44 percent of public sector service users have missed an appointment due to communication issues with the organisation. This soars to a staggering 70 percent of 18-24 year-olds.

Vonage’s independent survey of 2,000 UK adults who have contacted public sector organisations since the Covid-19 lockdown started*, revealed that more than a third (36 percent) felt extremely frustrated following their last interaction. Nearly half of those (46%) attributed this to not being able to make contact through their preferred communications channel. In fact, 27 percent of respondents reported that their favoured channel wasn’t available, despite 71 percent of those questioned stating this would have enhanced their experience.

According to the survey, 88 percent of respondents want public sector organisations to send them important messages directly, with email being the preferred channel for 43 percent, closely followed by SMS (41%). Twelve percent of 18-24 year-olds would like to be notified viaFacebook Messenger, while 15 percent of 25-34 year-olds chose WhatsApp. These figures will likely increase as the younger generation matures.

When asked about their favourite overall channel for contact from public sector organisations, respondents again chose email (33%) followed by SMS (25%). Top reasons cited for email were ‘the message is documented for reference’ and ‘I can easily respond if needed’ (both 47%). Those preferring SMS chose the channel as they ‘can be reached instantly, anywhere, any time’ (56%) and they are ‘unlikely to miss the message’ (55%).

NHS data shows that missed general practitioner (GP) appointments alone cost the NHS £216 million a year, meaning the annual cost to the public purse of all these missed appointments across the sector is likely to be significant.

David Darmon, Vonage Vice President of Sales for EMEA, commented, “The fact that almost half of those surveyed, and almost three-quarters of 18-24-year-olds, have missed appointments due to these issues points to a growing problem in how the public sector communicates with its citizens.

“Sending out letters may have worked well enough in the past, with only 18 percent of those over 55 having missed an appointment, but preferences are changing rapidly, with our research highlighting that this age group now favour email (46%) and SMS (23%).

“We are at the start of a communications revolution as organisations worldwide accelerate their digital transformation journeys to offer a better customer experience, increasingly recognising that it’s a key competitive differentiator. This research highlights that in an increasingly virtual world, it is essential for public sector organisations to stay connected to service users from anywhere through their preferred communications methods as the demand for exceptional customer experiences has never been greater”.

Vonage is a supplier on Crown Commercial Service’s (CCS) G-Cloud framework for its Messages API, together with its Vonage Business Communications and Vonage Contact Center solutions. The G-Cloud framework enables public sector organisations to search, evaluate and procure cloud services from select suppliers. CCS supports the public sector to achieve maximum commercial value when procuring common goods and services. In 2019/20, CCS helped the public sector to achieve commercial benefits worth over £1bn, supporting world-class public services that offer the best value for taxpayers.

Vonage delivers an end-to-end communication experience, from unified communications to contact centres to communications APIs that enable the integration of video, voice, messaging, chat and verification into customers’ applications, products and workflows. The Vonage Messages API integrates with SMS, MMS and popular social chat apps — such as WhatsApp, Facebook Messenger and Viber — so organisations can communicate with customers throughout their journey to engage them, fulfil their requirements and provide real-time support.

For further information, download the research report.

*Research conducted via London-based insights agency, Opinion Matters. Sample: 2,003 UK-based adults who have had reason to be in contact with public sector organisations since the Covid-19 lockdown started. Field dates: 27.05.2021-03.06.2021.

###

About Vonage

Vonage (Nasdaq: VG), a global cloud communications leader, helps businesses accelerate their digital transformation. Vonage’s Communications Platform is fully programmable and allows for the integration of Video, Voice, Chat, Messaging and Verification into existing products, workflows and systems. Vonage’s fully programmable unified communications and contact center applications are built from the Vonage platform and enable companies to transform how they communicate and operate from the office or anywhere, providing enormous flexibility and ensuring business continuity.

Vonage Holdings Corp. is headquartered in New Jersey, with offices throughout the United States, Europe and Asia.

Vonage PR Contact

Nicola Brookes

+44 (0)125 659 7454

[email protected]

Vonage Investor Contact

Hunter Blankenbaker

+1 732-444-4926

[email protected]

KEYWORDS: United Kingdom Europe

INDUSTRY KEYWORDS: Other Consumer Technology Mobile/Wireless Other Communications Marketing Telecommunications Communications Consumer VoIP

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KVH Provides AgilePlans VSAT Services for Briese Schiffahrt Vessels and Crew

The AgilePlans program accelerates HTS VSAT adoption as a monthly subscription with no costly CAPEX

MIDDLETOWN, R.I., Sept. 16, 2021 (GLOBE NEWSWIRE) — KVH Industries, Inc., (Nasdaq: KVHI), announces its successful and expanding AgilePlans relationship with established customer German shipmanager Briese Schiffahrt, which has rapidly grown its installed base over the last two years from 5 to 38 vessels with plans to continue. The flexibility of KVH’s no-commitment AgilePlans® program and the reliability of the global VSAT services in supporting critical operational usage and crew communications were cited by the company as reasons for selecting KVH.

“For us, it is very important to work with a company that is able to provide the ease and flexibility of paying monthly without any commitment worries,” says Holger Börchers, IT manager for Briese Schiffahrt. “It shows that KVH understands the commercial maritime market and the fact that fleet sizes change.” He adds: “KVH AgilePlans provides full coverage of all fees in one price and we have found working with KVH to be seamless.”

The arrangement was facilitated by Heiko Höfer, managing director of Dualog Nordic GmbH, KVH’s airtime service provider in Germany. “Our success here is owing to the close-knit relationships of trust, support, and dependability that have been forged in the local market over many years,” says Thomas Plüschau, KVH regional sales manager for Germany. “These strong and positive working relationships, combined with the power of AgilePlans, enables us to help drive change, modernization, and business in critical shipping hubs.”

Briese Schiffahrt manages a fleet of project cargo vessels, bulk carriers, and containerships, and also performs crew management for more than 2,000 seafarers. The shipmanager values KVH’s satellite connectivity services for the improved communications between office and vessels and for the ease of managing crew accounts, according to Mr. Börchers. “Every morning, our crew program is synchronized and when a seafarer steps on a KVH-equipped vessel, it automatically recognizes the crew member and provides the appropriate Internet access,” he says. “We know that we need to offer good connectivity in order to get and keep good crew members. Our plan is to equip every vessel that is sailing on waters more than 50 miles from the coast with VSAT.”

Nearly all of the 38 KVH-equipped Briese Schiffahrt vessels use the TracPhone® V7-HTS, a 60 cm diameter satellite communications antenna system designed to provide data speeds up to 10 Mbps down/3 Mbps up. Two vessels use the TracPhone V3-HTS, a 39 cm diameter system featuring data speeds up to 6 Mbps down/2 Mbps up, and one vessel uses the TracPhone V11-HTS, a 1-meter diameter system featuring data speeds up to 20 Mbps down/3 Mbps up. Mr. Börchers adds: “Briese will build a number of new vessels during the next years and all of them will be equipped with a KVH V11-HTS. The very first of this new generation is planned to be delivered in mid-November.”

The AgilePlans program also includes the NEWSlinkTM service, which enables seafarers on the Briese Schiffahrt vessels to access daily news content from around the world, an important aspect of crew welfare. The NEWSlink service includes more than 65 national seafarer news dailies in more than 20 languages, plus monthly special interest editions.

KVH AgilePlans is a Connectivity as a Service (CaaS) subscription-based model offering a comprehensive solution for maritime satellite communications. Without a costly capital outlay, the AgilePlans service eliminates barriers to upgrading to VSAT or switching from a competitor. It includes high-speed connectivity with unlimited email and texting via KVH’s mini-VSAT BroadbandSM HTS network, TracPhone HTS-series hardware, installation in as many as 4,000 ports and locations, cybersecurity protection, NEWSlink print and TV news content, KVH OneCareTM maintenance, and no long-term commitment, all for one monthly fee.

KVH’s HTS network utilizes Intelsat’s FlexMaritime service to deliver global multi-layered coverage, enabling vessels to see multiple HTS and wide beam satellites for maximum availability of broadband service.

Note to Editors: For more information about KVH AgilePlans, please visit kvh.com/agileplans. High-resolution images of KVH products are available at the KVH Press Room Image Library, kvh.com/Press-Room/Image-Library.

About Briese Schiffahrt

Briese Schiffahrt, headquartered in Leer, Germany, manages a fleet of more than 130 multipurpose vessels including project cargo vessels, bulk cargo vessels, and containerships. The company provides a wide range of integrated maritime services and is committed to high safety standards, state-of-the-art equipment, and qualified and well-trained crews.

About KVH Industries, Inc.

KVH Industries, Inc., is a global leader in mobile connectivity and inertial navigation systems, innovating to enable a mobile world. A market leader in maritime VSAT, KVH designs, manufactures, and provides connectivity and content services globally. KVH is also a premier manufacturer of high-performance sensors and integrated inertial systems for defense and commercial applications. Founded in 1982, the company is based in Middletown, RI, with research, development, and manufacturing operations in Middletown, RI, and Tinley Park, IL, and more than a dozen offices around the globe.

This press release contains forward-looking statements that involve risks and uncertainties. For example, forward-looking statements include statements regarding the success of our strategic initiatives; our anticipated revenue and the impact of our future initiatives on revenue; competitive positioning and profitability; expected data speeds over our network and the expected level of coverage availability; and the services to be provided under agreement with Briese Schiffahrt. The actual results we achieve could differ materially from the statements made in this press release. Factors that might cause these differences include, but are not limited to, the uncertain duration of the adverse impact on our overall revenues of our AgilePlans, under which we recognize no revenues for product sales, either at the time of shipment or over the contract term; delays in the receipt of anticipated AgilePlans service orders; the potential failure of such AgilePlans orders to occur at all and the customer’s ability to cancel AgilePlans at any time; increased costs arising from the new HTS network; potential levels of customer demand for data services beyond our current expectations, which could exceed system capabilities in certain regions; and potential unforeseen costs or expenses of providing the products and services included in AgilePlans. These and other factors are discussed in more detail in KVH’s Form 10-Q filed with the SEC on July 30, 2021. Copies are available through its Investor Relations department and website, investors.kvh.com. KVH does not assume any obligation to update its forward-looking statements to reflect new information and developments. 

KVH Industries, Inc., has used, registered, or applied to register its trademarks in the U.S.A. and other countries around the world, including but not limited to the following marks: KVH, AgilePlans, NEWSlink, mini-VSAT Broadband, TracPhone, and KVH OneCare. All other trademarks are the property of their respective companies.

For further information, please contact:

Jill Connors
Sr. Manager, Media & Industry Analyst Relations
KVH Industries, Inc.
Tel: +1 401 851 3824
[email protected]



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MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021

  • 21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A
  • 78% of patients had tumor shrinkage at first scan
  • Median duration of response was 10.3 months as of data cutoff
  • Margetuximab plus retifanlimab was well tolerated with Grade 3 treatment-related adverse events (TRAEs) in 19% of patients; no Grade 4 TRAEs or treatment-related deaths
  • Findings suggest this chemotherapy-free combination, if validated and approved, may be a potential option for first-line HER2+ patients

ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced results from Cohort A Part 1 of the Phase 2/3 MAHOGANY clinical trial of margetuximab. MARGENZA® (margetuximab-cmkb) is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ gastric cancer (GC) or gastroesophageal junction (GEJ) cancer in combination with a checkpoint inhibitor, with or without chemotherapy. The dataset is available in a poster titled “Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A” (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

The efficacy data and safety cutoff dates were July 19, 2021 and August 3, 2021, respectively. In Cohort A Parts 1 and 2, the efficacy and safety of combining margetuximab and retifanlimab (investigational anti-PD-1 monoclonal antibody licensed to Incyte by MacroGenics) is planned to be evaluated in approximately 100 patients whose tumors are HER2+ at the 3+ level by immunohistochemical (IHC) staining, PD-L1+ (combined positive score ≥1%) and non-microsatellite instability-high (non-MSI-H). A pre-specified interim analysis assessing efficacy and safety was conducted on the first 40 non-MSI-H patients enrolled in Part 1. These data support advancement to Part 2 with plans to enroll approximately 60 additional response-evaluable non-MSI-H patients.

A total of 43 HER2 3+ and PD-L1+ patients were enrolled in Cohort A Part 1 and received margetuximab 15 mg/kg plus retifanlimab 375 mg/kg administered intravenously every three weeks. Twenty-five patients (58%) had gastric cancer and 18 patients (42%) had gastroesophageal junction cancer; 36 patients (84%) had metastatic disease at study entry.

MAHOGANY Cohort A Interim Analysis

Anti-tumor activity was observed in patients treated with margetuximab plus retifanlimab in MAHOGANY Cohort A after the first scan. Tumor shrinkage was observed in 32 of 41 patients (78%) with at least one post-baseline target lesion measurement. Twenty-one of 40 response-evaluable patients achieved an objective response (53%, 95% confidence interval (CI): 36%-69%), including four confirmed complete responses and 17 confirmed partial responses. The number of confirmed responders by independent assessment exceeded the prespecified futility boundary for the trial, and enrollment is proceeding to Cohort A Part 2.

Disease control was achieved in 29 of 40 patients (73%, CI: 56%-85%) and the median duration of response was 10.3 months (range: 2.1 – 14.5 months, CI: 4.6 months – not evaluable (NE)). Median progression-free survival (PFS) was 6.4 months by independent assessment (CI: 6.0 months – NE); median overall survival (OS) was not yet reached. At both 12 and 18 months, OS was 85% (CI: 63%-95%).

Antitumor activity was comparable to historical data from the experimental arm of the Trastuzumab for Gastric Cancer (ToGA) study (trastuzumab + chemotherapy; n=294; objective response rate (ORR) of 47%; median duration of response (DOR) of 6.9 months)1 and initial data from the control arm (placebo + trastuzumab + chemotherapy) of the KEYNOTE‐811 study (ORR of 52%; median DOR of 9.5 months).2

The safety analysis of all 43 patients treated with margetuximab plus retifanlimab suggests the combination was well tolerated in the study population. The most common TRAEs were fatigue (21% Grade 1-2, 0% Grade ≥3), infusion-related reaction (19% Grade 1-2, 0% Grade ≥3), rash (19% Grade 1-2, 0% Grade ≥3), diarrhea (16% Grade 1-2, 2% Grade 3), and pruritus (16% Grade 1-2, 0% Grade ≥3). A total of nine Grade 3 TRAEs were reported in eight patients (19%); no Grade 4 TRAEs were observed. Eight serious TRAEs were reported in seven patients. Infusion-related reactions considered as adverse events (AEs) of special interest occurred in six patients.

Treatment-emergent AEs of Grade 3 occurred in 18 of 43 patients (42%) of patients. Three of 43 patients (7%) discontinued therapy due to immune-related AEs: renal dysfunction (Grade 3), hepatitis (Grade 3), and diabetic ketoacidosis (Grade 1); no AEs led to death.

Safety data from MAHOGANY compare favorably to the experimental arm of ToGA in which overall Grade 3-4 AEs were 68% and the treatment-related mortality was 3%.1 Initial results from KEYNOTE-811 data presented at the 2021 ASCO Annual Meeting indicated that AEs of Grade 3-5 occurred in 57.1% of patients in the experimental arm (pembrolizumab + trastuzumab + chemotherapy) and in 57.4% of patients in the control arm, AEs leading to death occurred in 3.2% vs 4.6%, and AEs leading to discontinuation of any study drug occurred in 24.4% vs 25.9% of patients, respectively. Despite limitations of cross-study comparisons, regimens containing chemotherapy may have clinically relevant safety differences compared to the chemotherapy-free regimen in MAHOGANY Cohort A.

“We are excited to share our results from the interim analysis of Part 1 of the MAHOGANY Cohort A study at ESMO,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “This study is designed to support potential registration of margetuximab in combination with other agents for patients with gastric or gastroesophageal junction cancer as part of our strategy to advance margetuximab in HER2+ cancer. The findings suggest the combination of margetuximab and retifanlimab may potentially provide a chemotherapy-free option as a first-line treatment for patients whose tumors are positive for both HER2 and PD-L1. We are pleased these data support the protocol’s prespecified advancement into Part 2 of MAHOGANY Cohort A. We plan to discuss these results and future development of the combination in an upcoming scheduled meeting with the FDA.”

ESMO Presentation

MacroGenics’ Cohort A Part 1 MAHOGANY Study poster presentation is available for on-demand viewing on the ESMO website and on the “Events & Presentations” page on MacroGenics’ website at http://ir.macrogenics.com/events.cfm.

The MAHOGANY Study Design

MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two cohorts designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2+ GEJ/GC.

Cohort A is designed as a single arm study to test margetuximab plus retifanlimab (previously known as MGA012 and INCMGA00012), an investigational anti-PD-1 monoclonal antibody, in patients with HER2+ and PD-L1+ tumors. The primary outcome measure for efficacy is ORR per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Cohort B is designed as a randomized trial to test margetuximab plus a checkpoint inhibitor in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2+ tumors irrespective of PD-L1 expression. Patients randomized to one of two experimental arms containing a checkpoint inhibitor will receive either retifanlimab or tebotelimab (previously known as MGD013), an investigational DART® molecule targeting PD-1 and LAG-3. The primary outcome measure for efficacy is OS.

The Phase 2/3 clinical trial is being conducted at clinical sites globally, in collaboration with Zai Lab, the company’s regional partner in Greater China. For additional information about the MAHOGANY study, please visit https://clinicaltrials.gov/ct2/show/NCT04082364.

About Gastric and Gastroesophageal Junction Cancer

Cancer of the stomach (gastric cancer, GC), or the gastroesophageal junction (GEJ) where the esophagus joins the stomach, is collectively known as gastroesophageal adenocarcinoma and is the fifth most common tumor type worldwide. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2+.

About Margetuximab

MARGENZA® (margetuximab-cmkb) is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ GC or GEJ cancer in combination with a checkpoint inhibitor, with or without chemotherapy. Margetuximab is an Fc-engineered monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors.  Through MacroGenics’ Fc Optimization technology, margetuximab has been engineered to enhance the engagement of the immune system.

Margetuximab is also being evaluated in combination with tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in various HER2+ tumors (NCT03219268). MacroGenics is partnered with Zai Lab for the development and commercialization of margetuximab in Greater China. For more information, please visit www.clinicaltrials.gov.

About Retifanlimab

Retifanlimab is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under an exclusive global collaboration and license agreement. MacroGenics retains the right to develop its pipeline molecules with retifanlimab. Incyte is pursuing development of retifanlimab monotherapy in four potentially registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma, anal cancer and non-small cell lung cancer. Incyte and MacroGenics are each conducting multiple studies of retifanlimab in combination with other agents.

About Tebotelimab

Tebotelimab is an investigational, first-in-class bispecific DART molecule designed to provide co-blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies.

About MacroGenics, Inc.

MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including enrollment in clinical trials, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential, ” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA’s market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

1 Bang YJ, et al., Lancet. 2010; 376 (9742): 687-697.

2 Janjigian YY, et al., J Clin Oncol. 2021; 39 (suppl 15): 4013.



CONTACTS:
Chris James, M.D., Vice President, Investor Relations & Corporate Communications
Jim Karrels, Senior Vice President, CFO
1-301-251-5172,  [email protected]

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MacroGenics Announces Preliminary Clinical Results from Phase 1 Cohort Expansion of the Ongoing MGC018 Study Presented at ESMO 2021 Virtual Annual Congress

  • Metastatic castration-resistant prostate cancer (mCRPC): 21 of 39 patients (54%) achieved ≥ 50% prostate-specific antigen (PSA) reduction; 10 of 16 (63%) RECIST-evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved partial responses (two confirmed and two unconfirmed)
  • Non-small cell lung cancer (NSCLC): 13 of 16 (81%) evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved unconfirmed partial responses
  • Manageable safety profile overall, with low rate (7%) of discontinuation due to treatment-related adverse events (TRAEs)

ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from dose expansion cohorts of the Company’s ongoing Phase 1 clinical trial of MGC018. This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA-alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset is being presented in a poster titled “MGC018, an Anti-B7-H3 Antibody-Drug Conjugate (ADC), in Patients with Advanced Solid Tumors: Preliminary Results of Phase 1 Cohort Expansion” (Poster #620P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

Cohort Expansion Results Update

As of the August 16, 2021 data cut-off, a total of 86 patients with advanced solid tumors were enrolled in the cohort expansion of MGC018 at the recommended Phase 2 dose (RP2D) of 3.0 mg/kg, administered intravenously every three weeks. The enrollment includes 40 patients with mCRPC, 21 patients with NSCLC, 16 patients with triple negative breast cancer (TNBC) and nine patients with melanoma. In addition, enrollment of patients with squamous cell carcinoma of the head and neck (SCCHN) was recently initiated. The safety analysis both in the poster and below includes all enrolled patients, whereas the efficacy analysis was limited to mCRPC and NSCLC patients, as enrollment continues in the other tumor cohorts.

In the cohort expansion, tumor response by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) was evaluated every nine weeks for all patients and PSA was assessed every three weeks in mCRPC.

Preliminary Anti-tumor Results for mCRPC Cohort Expansion

As of the August 16, 2021 data cut-off, all 40 patients in the mCRPC cohort expansion had been enrolled. Patients had previously received a median of three prior therapies for advanced disease, with all 40 patients having received both chemotherapy and next-generation hormonal therapy. The median B7-H3 H-score for all mCRPC patients was 223.

A total of 39 mCRPC patients were evaluable for PSA response. Reductions in PSA levels of ≥ 50% were observed in 21 of 39 patients (54%). Twenty-four of the 39 patients (62%) remained on treatment as of the data cut-off.

Of the 40 patients in the mCRPC cohort, 16 of the 23 patients with measurable disease were evaluable for tumor response by RECIST as of the data cut-off. Ten of these 16 patients (63%) had reductions in their target lesion sums from baseline. Four patients (25%) demonstrated a partial response (PR), consisting of two confirmed and two unconfirmed PRs. Treatment was ongoing in six of 16 patients with evaluable tumor response as of the data cut-off.

Preliminary Anti-tumor Results for NSCLC Cohort Expansion

As of the August 16, 2021 data cut-off, the NSCLC cohort expansion had been fully enrolled with 21 patients. Patients had previously received a median of two prior therapies for advanced disease, with 15 (71%) having previously received anti-PD-1/PD-L1 therapy. The median B7-H3 H-score for these patients was 139.

A total of 16 NSCLC patients were evaluable for tumor response by RECIST. Thirteen of 16 (81%) patients had reductions in their target lesion sums from baseline. Four of these 16 patients (25%) experienced unconfirmed partial responses. Another one of these 16 patients experienced a 30% reduction in target lesions; however, the patient’s non-target lesions were not evaluated due to an obstruction of the bronchus and overall response was not evaluable. Treatment was ongoing in seven of 16 patients as of the data cut-off.

Preliminary Safety Results

The safety analysis includes all 86 patients enrolled in the cohort expansion as of the August 16, 2021 data cut-off. The median number of doses received by mCRPC patients was 3.5 (range: 1-8); those with NSCLC received 3.0 (range: 1-7). Adverse events for the dose expansion cohorts of 3 mg/kg were generally consistent with those previously reported at ASCO 2021. TRAEs included hematologic and skin toxicities that have been clinically manageable to date. In the cohort expansion study overall, at least one TRAE of any grade was experienced by 78 of 86 patients (91%), with 43 of 86 patients (50%) experiencing a Grade ≥3 TRAE.  There were two Grade 5 fatal events: one from an unknown cause and one due to SARS-CoV-2.

The most common TRAEs were fatigue (37% all grades; 1% Grade ≥3), neutropenia (34% all grades; 22% Grade ≥3), palmar plantar erythrodysesthesia syndrome (31% all grades; 4% Grade ≥3), pleural effusion (23% all grades; 1% Grade ≥3), nausea (22% all grades; 1% Grade ≥3), asthenia (20% all grades; 5% Grade ≥3) and thrombocytopenia (14% all grades; 7% Grade ≥3). The overall results have demonstrated a manageable safety profile with a low rate of treatment discontinuation due to TRAEs: only six of 86 (7%) patients had discontinued therapy in the cohort expansion as of the data cut-off date due to TRAEs.

“We are highly encouraged by the growing data from our ongoing Phase 1 study of MGC018,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Consistent with previously presented data, we observed PSA reductions of 50% or greater in 54% of patients with metastatic castration-resistant prostate cancer. And now, we are particularly pleased to see partial responses emerge – both confirmed and unconfirmed – in mCRPC and NSCLC patients, with encouraging anti-tumor activity observed in the majority of patients for both tumor types. Also, we are very pleased with the evolving safety profile of MGC018, which showed neutropenia as the only Grade 3 or higher TRAE that exceeded a rate of 10% in this trial. Finally, further optimization of patient management has resulted in a low rate of MGC018 discontinuation due to TRAEs as of the data cutoff. Enrollment is ongoing in the TNBC, SCCHN, and melanoma cohorts and we look forward to providing further updates on patients in these cohorts, as well as patients in the mCRPC and NSCLC cohorts, at subsequent scientific conferences.”

ESMO Presentation

MacroGenics’ MGC018 poster presentation is available for on-demand viewing on the ESMO website and on the “Events & Presentations” page on MacroGenics’ website at http://ir.macrogenics.com/events.cfm.

About MGC018

MGC018 is an ADC comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. B7-H3 is a molecule highly expressed on many solid tumors and associated with a poor clinical outcome. MGC018 is being evaluated in a Phase 1 study (NCT03729596). MacroGenics retains worldwide rights to MGC018.

About MacroGenics, Inc.

MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including enrollment in clinical trials, commercial prospects of or product revenues from MARGENZA®, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA’s market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.



CONTACTS:
Chris James, M.D., Vice President, Investor Relations & Corporate Communications
Jim Karrels, Senior Vice President, CFO
1-301-251-5172,  [email protected]

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Leap Therapeutics Presents Updated Positive Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO Congress

– DKN-01 plus tislelizumab and chemotherapy demonstrated compelling activity in first-line patients with gastric or gastroesophageal junction cancer

– Additional data presented today showed responses to treatment are independent of PD-L1 expression, with 79% ORR in patients with PD-L1 low (CPS < 5) tumors

– Company to host conference call on Friday, September 17, 2021 at 8:00 a.m. ET

PR Newswire

CAMBRIDGE, Mass., Sept. 16, 2021 /PRNewswire/ — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused  on developing targeted and immuno-oncology therapeutics, today announced the presentation of updated positive data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) Congress. The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

The Company announced positive initial data from the DisTinGuish study on Monday, September 13, 2021 based on 25 G/GEJ patients enrolled in the trial that showed DKN-01 in combination with tislelizumab and chemotherapy as first-line therapy was well tolerated with compelling activity. The results presented at the ESMO Congress today included additional patient data stratified by tumoral PD-L1 expression levels based on visually-estimated combined positive score (vCPS), showing that robust objective clinical responses can be achieved from this combination regimen independently of PD-L1 expression.

“Initial data from this trial have shown that patients with high levels of DKK1 expression, a group with a poor prognosis, had encouraging responses to treatment. The additional data presented today show evidence that not only is DKK1 a critical biomarker in predicting response to DKN-01 and tislelizumab therapy, but also that the combination can induce deep responses regardless of the patient’s PD-L1 status, including particularly poor prognosis patients with both low PD-L1 and high DKK1,” said Samuel Klempner, MD, Member of the Faculty at Massachusetts General Hospital Cancer Center and Harvard Medical School. “Taken together, these are promising results for the combination therapy of DKN-01 with tislelizumab and chemotherapy in first line patients with gastric or gastroesophageal junction cancers.”

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Key Findings

  • Among patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients
  • Response was independent of PD-L1 expression, and particularly strong in the less favorable to checkpoint inhibitor therapy, PD-L1 low (vCPS < 5), population
    • Among those patients with PD-L1-low expression (vCPS < 5), the ORR was 79%, with 100% in DKK1-high patients and 57% in DKK1-low patients
    • Among those patients with PD-L1-high expression (vCPS ≥ 5), the ORR was 67%, with 75% ORR in DKK1-high patients and 50% in DKK1-low patients
    • DKK1 levels could not be determined in one patient who had PD-L1 expression data; however, the patient’s PD-L1 expression level was determined to be low (vCPS score 0) and the patient achieved a partial response
  • DKK1 expression and PD-L1 expression are not correlated
  • Median duration of response and progression-free survival data are not yet mature, and patient follow-up continues

Twenty-five first-line patients were enrolled, and as of the cut-off date of the presentation, 15 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), and three patients were unable to complete a full cycle of DKN-01 therapy (non-modified ITT (mITT)).

Among the 21 patients that had RNAscope® DKK1 expression available, 12 were DKK1-high [9 PR, 1 NE, 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD]. 

Among the 20 patients that had PD-L1 expression available, 14 were PD-L1 low vCPS < 5 [11 PR, 3 SD] and 6 were PD-L1 high vCPS > 5 [4 PR, 1 SD, 1 NE].

A copy of the poster presentation is available on the Company’s website at https://www.leaptx.com/our-pipeline.

Conference Call

Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr. Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company’s website at https://investors.leaptx.com/, where a replay of the event will also be available for a limited time.

About Leap Therapeutics

Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. For more information about Leap Therapeutics, visit http://www.leaptx.com or view our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.

RNAscope® is a registered trademark of Advanced Cell Diagnostics, Inc., Newark, CA, USA.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap’s expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestone, or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the SEC, including Leap’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on March 12, 2021 and as may be updated by Leap’s Quarterly Reports on Form 10-Q and the other reports Leap files from time to time with the SEC. Any forward-looking statement contained in this release speaks only as of its date. Leap undertakes no obligation to update any forward-looking statement contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT:

Douglas E. Onsi

President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
[email protected]

Heather Savelle

Investor Relations
Argot Partners
212-600-1902
[email protected]

 

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SOURCE Leap Therapeutics, Inc.

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Oracle and Oxford Nanopore Team Up to Improve Healthcare and Speed Discovery of New Medical Breakthroughs

Technology leaders to jointly explore accessible, high-performance DNA/RNA sequencing solutions powered by Oracle Cloud Infrastructure (OCI) to improve patient care and outcomes

PR Newswire

AUSTIN, Texas, Sept. 16, 2021 /PRNewswire/ — Advances in DNA/RNA sequencing promise to revolutionize how medical communities identify, detect, and treat diseases and manage public health threats. To make this technology more accessible and increase its impact, Oracle has teamed up with Oxford Nanopore Technologies, the company behind a new generation of high-performance, rapid, scalable, and accessible sequencing technology.

Oracle and Oxford Nanopore have recently begun a collaboration to jointly explore several potential new solutions that would use genomic sequencing running on Oracle Cloud Infrastructure (OCI) to help speed medical breakthroughs and improve patient care.

Scientific researchers in more than 100 countries are already using nanopore sequencing to further their understanding of biology in a range of areas including human and cancer genetics as well as plant, animal, and environmental analyses. In addition, nanopore sequencing has been used for pathogen analysis, including the outbreak surveillance of tuberculosis, food-borne pathogens, Ebola, Zika, Lassa fever, dengue fever, influenza, and most recently COVID-19.  

As part of the collaboration, Oxford Nanopore will be using OCI in applied and clinical markets. Leveraging the high performance, security, and extensive reach of Oracle Cloud, Oracle and Oxford Nanopore will have the ability to extend population-scale genetic sequencing across the globe.

The organizations will also take on several ambitious projects spanning epidemiology, whole-genome sequencing, and healthcare and drug discovery. This includes integrating Oxford Nanopore’s DNA/RNA sequencing capabilities and data into Oracle’s broad portfolio of healthcare and life sciences applications to strengthen the links between genomics, medical treatment, and drug development.

“Oxford Nanopore’s innovative sequencing technology is unparalleled in the market for its ability to generate rich, accurate genomic data at any scale, from handheld devices to ultra-high output installations,” said Mike Sicilia, executive vice president of Oracle Vertical Industries. “By integrating genomic data into our existing applications and cloud infrastructure solutions, we can get these powerful tools into the hands of more people to solve critical health issues faster and improve patient outcomes to usher in a new era of genomic breakthrough.”

In parallel, Oracle has committed to investing £150 million in Oxford Nanopore, subject to customary conditions.

About Oracle
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at oracle.com.

Trademarks
Oracle, Java, and MySQL are registered trademarks of Oracle Corporation.

“Safe Harbor” Statement
This press release contains forward-looking statements including, among other things, statements relating to (1) a memorandum of understanding between Oracle and Oxford Nanopore Technologies, whereby the two companies will explore collaboratively a number of potential new solutions to address opportunities in applied and clinical markets and related go-to-market strategies, including Oxford Nanopore Technologies’ migration of its EPI2ME platform to the Oracle Cloud Infrastructure and (2) Oracle’s commitment to invest $150 million in Oxford Nanopore Technologies. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The degree to which the parties collaborate, the migration of the platform and the success of the foregoing, as well as the consummation of the investment, are subject to many factors that could cause actual results to differ materially. A detailed discussion of these factors and other risks that affect our business is contained in our SEC filings, including our most recent reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.” All information set forth in this press release is current as of September [13], 2021. Oracle undertakes no duty to update any statement in light of new information or future events.

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SOURCE Oracle